What Factors Need To Be Considered When Formulating Packaging

 Excellent physical characteristics are suitable for high-end market applications

Breathable, excellent resistance to bacteria.

Suitable for various sterilization methods (steam sterilization under certain conditions)

Low biological load: community forming unit /SqFt< = 100

Used with special easy-to-peel materials,

Why coating? Why not just heat seal it?

1. Enhance the heat sealing range and peeling effect

2. Wide range of matching materials -- hard (PVC,PETG, HPS) and FLEXIBLE PE

3. Wide range of heat sealing temperature

4. Good heat sealing and clean stripping

5. Improved microbial barriers

Air permeable coated paper /Tyek: paper and reinforced paper to TYvek

Iso11607-1, mostly :EN868-6 and sometimes :EN868-3)

Main products:

1. Full coated paper

2. Full plate coated reinforcing paper

3 Full plate coating Tyvek

Full plate coated reinforcement paper (top material)

Full plate coated reinforcement paper:

1. Plain and reinforced paper with 3-8g coating (60g - 80g base paper).

2. High strength and puncture resistance, excellent resistance to water and bacteria barrier.

3. Heat sealing strength is appropriate, and clean stripping

4. High speed operation on bag-making machine - excellent tolerance for machine changes.

It came into being in the mid-1990s

Impermeability, limited to radiation and e-B sterilization

Can be used for three side sealing machine and FFS machine.

A reasonable operating range, depending on the customer's requirements for an acceptable heat seal strength range.

Heat seal strength can be set according to requirements

Film type

1.PET/PE NY/PE PET/CPP

2.PET/ easy to peel film

3. With different materials, can be suitable for specific sterilization

PET/PE

1.PET/PE is a very common material

2. Common specifications :PET2/PE50, PET12/PE40,PET12/ PE-PEelable50, etc

Etc.

3. Common colors: white, transparent products.

4. Matching material: easy to peel with most

5. Disinfection method: Ray, ETO(when used with breathable material).

PET/CPP

1. Common specifications :PET12/CPP28 to PET12/ CPover 100 thicknesses

2. Disinfection method :121C~134C steam sterilization

3. Matching materials: Most of the products are made into hospital sterilization pouches with high-temperature disinfection paper

PE110 top bag film, linear tear PE film and so on

With related permeable materials, EO sterilization or ray sterilization can be used.

The cost is lower than the composite film;

Soft;

It can't be printed inside.

The main factors that need to be considered when selecting thermoplastic forming film

MDMS products:

Hard products:

Small products: syringe, V device. Heavy duty products: endoscopy equipment.

Soft products:

Small products: gloves, dressings, catheters, large volume products, surgical gown, surgical kits.

Feature products:

Used for steam sterilization.

For heat seal/uncoated Tyvek

Film design and development

1. Durable thorn

2. Friction performance

3. Thermoplastic forming ability

4. Reserve volume

5. Side and corner specifications

6. Feature product: Specific situation - specific design and development

Hard products: Films may be damaged by abrasion or perforation (syringe devices, devices with sharp angles or sharp edges)

Films made of Surlyn (ray and epoxy)

Advantages:

1. Excellent formability

2. Excellent physical properties

3. Good specification of corner

4. Excellent retention volume

5. Excellent transparency

6. Excellent shape retention (semi-rigid)

Suitable for hard products and deep molding.

Typical construction: EVA/Surlyn

Normal thickness: various, 100-350 micron

The percentage of Surlyn varies to balance film thickness and variations (depth and shape) during thermoplastic forming

A film made of nylon. Sterilization method (determined by heat sealing layer)

1. Medium volume retention

2. Excellent corner specification

3. The film has strong wear/good puncture performance

4.PA/PE or PP/PAPE: For direct heat sealing of uncoated paper (ETO/ ray sterilization)

→ Is suitable for trauma care products, syringes, catheters, etc.

5.PA/PP: direct heat sealing and steam sterilization with high temperature sterilizing paper

6.PE/PA/PE: Heat seal with coated top film - good retention volume

7.PA/ Easy stripping film and Rayopeel: Can be used for uncoated Tyevk heat sealing.

Conventional thickness: Nylon film,(60-250) micron.

PP/PE or special polyolefin membrane

Films made from polyolefin (ethylene oxide/some structures are radio-sterilized)

Suitable for soft products commonly used film

There are many kinds of PE in the market - diversified formula to meet different requirements.

Material selection: unnecessary restraint

This is a common mistake

1. 15N/15mm as described in Part 5 of EN868 -- however, this part is for hospital bags and tube bags and not for packages made by the medical device customer on its own packaging machine, at the discretion of the medical device customer.

2.1.5N is the maximum sealing strength (peak value) recorded during the testing process.

3. No test method number. It is only described in the standard. The test sample is stretched at a speed of 200-300mm/min, and the tail is not supported, but the maximum force is recorded.

Generally recognized internationally as the determinants of good packaging:

1. Determine the processing scope of packaging machine, and make sample → transport research from all the processing scope.

2. Appropriate transport studies by certification bodies. Inspection standard: | STA ASTM

3. When your packaging design has been properly studied for transportation by a certification body, you are confirmed and approved that your packaging will protect the safety of the product in transportation.

4. Conduct appropriate post-sterilization aging tests (heat sealing and physical properties of materials) to ensure a 5-year shelf life.

5. Use materials that meet the requirements of international medical packaging standards.

Factors to consider before developing packaging methods:

1. Packaging scheme: contents, packaging equipment, packaging requirements, sterilization method

2. Contents:

Structure, size, weight, hardness, softness and shape

Protection required: transport studies, water resistance, oxygen resistance, light/uv barrier

Every year the dosage

Features:

1. The fragile

2. Sharp edges

3. Three-dimensional space vs. flat

4. Heavy

5. Size large

6. Multiple ingredients

7. High price vs. Low price

8. Contains a liquid component

The packaging must allow gas to pass through

1. Over a period of time (less than 24 hours), blow the gas into the package placed in the room and then extract the gas

2. There is gas residue in the package

3. Porous materials are required for packaging

4. The material must be air resistant

5. The heat resistance of the material is not important

6. Medium temperature (30°70℃)

7. Sterilization requires a warm and humid environment

8. Excessive sterilization will damage the package

9. Compatible with multiple materials

Most common packing

1. Ventilation bag

2. Use soft strong film structure sealing coating and uncoated Tyvek and uncoated paper

3. Cover stripping packaging

4. One side is Twek or paper with easy stripping film

Radiation can penetrate most materials (gamma rays penetrate deeper than electron beams)

1. Packaging does not require air permeability (materials are not required to breathe)

2. Destroy microbial DNA

3. Gamma-ray irradiation sources are cobalt-60 irradiation sources

4. Irradiation will damage packaging materials including paper, but it is polypropylene)

Most commonly used packaging:

1. Aerated and airtight bags

2. Use soft strong film structure sealing coating and uncoated Tyvek, coated and uncoated paper

3. Strip packaging

4. Multilayer aluminum film packaging

The material must be polycrystalline and resistant to heat and moisture

1. Sterilization method with the highest cost-benefit ratio

2. For use in most dental clinics and hospitals

3. The temperature is between 121℃ and 134℃

4. Depending on the length of sterilization cycle, the highest temperature can reach 140℃(234F)

5. Relevant materials must have high temperature resistance

6.PET, PP, PA and other common omentum

Most plain packaging:

1. Printing paper /PET/CPP(such as medical wrapping paper)

2.PVA paper/printing paper (such as medical gauze)

Category: Medical device application

Soft, small volume: gauze

Soft, large volume: surgical clothes, disinfection cover

Hard edge, small volume: syringes, INTRAVENOUS instruments, laboratory utensils, cocks

Valve, suture line

Hard edge, heavy quality: endoscope

Moisture-proof/Lodine: Brush


PA film -PA/PE, PA/PP, OPA/PE, OPA/PP

Films containing Surlyn

Strengthen the paper

Coated/uncoated Tyvek

 

Any thin material.

Paper for direct heat sealing.

· Polyolefin (PE) film, PP/PE

Single film bag.

Any thick material

EVA/Surlyn

100 g grid paper

Tyvek

Strengthen the paper

Top easy-to-peel membranes (e.g. Amcor Rayopeers and easy-to-peel membranes)

Various medical facilities

Bulk object

Medicinal gauze products

 

Syringes and needles

Conduits and fittings

gloves

Surgical coats and disinfectant covers

Intravenous apparatus

Special Series

1. Advanced wound care parts

2. The sutures

Medicinal gauze products

1. Suction sponge

2. Fold the gauze

Packing requirements:

1. Low cost

2. Steam, ethylene oxide or radiation sterilization

Possible packaging solutions

1. Paper /PE& adhesive paper

2. PET/PE& adhesive paper

3.PET/SPE& adhesive free paper

Syringes and needles

Mould plastic needles and pistons. With or without additional needles

Packaging requirements: low cost, impact resistance, wear resistance

Possible solutions:

1. Paper or coated paper &PA/PE co-extruded film

2. Paper or coated paper &PP/PE full film

Conduits and fittings

Pipe fittings products

Packaging requirements

1. Low cost (catheter)

2. Packages with multiple channels of sealing (usually 12 to 16 channels)

Possible packaging solution

1. Paper coated paper &PA/PE(PP/PE)

2. In the envelope

Surgical coats and disinfectant covers

Surgical gown and table cover

Packaging requirements

1. Impact resistance

2. Equipped with vacuum and non-vacuum

Possible packaging solutions

1. Coating paper /Tyvek&PA/PE molding film

2. Head bag

3. Adhesive paper & PET/PE film

gloves

Surgical and examination gloves

Packaging requirements

1. Radiation sterilization

2. High-speed packaging line

Possible packaging solutions

1.PET/PE& PET/SPE

2. Paper/ Coated Paper &PET/ PE or Paper/PE)